Regardless of the type of cell therapy product or the medical indication, the production of cell-based therapeutics is highly complex. Minaris Regenerative Medicine offers you comprehensive manufacturing experience, fully compliant with the relevant regional regulatory requirements of our global facilities in North America, Europe, and Asia.
Over the last 20 years, Minaris Regenerative Medicine has accompanied and driven the development of the cell and gene therapy industry.
We have served the clinical manufacturing programs of more than 180 clients with cGMP Manufacturing (FDA guidelines) and GMP Manufacturing (EMA guidelines). We listen to your needs, learn your specific challenges and goals, and customize a clinical manufacturing program for you to create a long-standing and trusting contract manufacturing partnership. We help you advancing through the phases of clinical development and optimizing your manufacturing process toward commercial viability.
Our GMP manufacturing capabilities include:
Whether you are looking ahead in anticipation of potential commercial production, should your product achieve the prerequisite regulatory approvals, or you have received such approval, Minaris Regenerative Medicine has commercial manufacturing capabilities and experience to serve your needs. We have established facilities in all our global regions with the systems and infrastructure needed to allow for commercial manufacturing, so that late-stage products can seamlessly transition into commercial production at our facilities.
For clinical applications and commercial use in Europe, we offer release by a Qualified Person (QP) for products manufactured in the EU as well as for products manufactured at our sites in the US or Japan for the European market.
A technology transfer for cell therapy manufacturing is the transmission of knowledge, experience, specifications, procedures, and other critical data to another organization/facility, such as a contract development and manufacturing organization (CDMO) with the goal of establishing GMP-compliant manufacturing as needed for the respective clinical stage and regulatory environment (FDA, EMA, or PMDA).
Minaris Regenerative Medicine has performed more than 70 successful tech transfers for cell therapy products in different clinical trial phases by taking a systematic and strategic approach to tech transfer.
Furthermore, through our technology transfer process, we don’t claim ownership of the cell therapy product, or any of the IP needed to manufacture it.